Treatment of Meibomian Gland Dysfunction

Meibomian Gland Dysfunction (MGD) Clinical Trial

Official title:

Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683318
• Other study ID #: R913/22/2012
• Status: Completed
• Phase: N/A
• First received: September 4, 2012
• Last updated: November 11, 2013
• Start date: September 2012

Study information

• Verified date: September 2012
• Source: Singapore National Eye Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

The current study aims to test the efficacy of treatment for a device that utilises a thermal pulsation system, which applies heat from the inner surface of the eyelids (Lipiflow) in patients suffering from meibomian gland dysfunction.

Patients will be asked to undergo a one-time treatment with Lipiflow and the investigators will monitor them for changes in tear film and lipid composition, as well as changes in the anatomy of meibomian glands for over a study period of 12 weeks. Additionally, dry eye symptoms will be documented in form of questionnaires.

The investigators hypothesize that the treatment will be effective in improving clinical signs and will relieve dry eye symptoms for the patient. If this method of managing Meibomian Gland Dysfunction (MGD) is found to be efficacious and safe, it will be made available to patients in Singapore.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Eyelids must present with blocked meibomian gland openings (plugs), at least 1 visible MG plug in the 4 eyelids, or discernable change in consistency of meibum (increased in viscosity or opacity) when MG expressed in upper or lower eyelids.

2. At least one out of 8 questions on dry eye symptoms is answered with often or all the time.

3. Eyes should not show any other ocular surface pathology which required more treatment than eye lubricant and conventional eyelid hygiene.

Exclusion Criteria:

1. Known history of thyroid disorders (diagnosed by physician).

2. No ocular surgery within the previous 6 months and LASIK within the previous 1 year.

3. Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.

4. Active ocular infection or pterygium.

5. Anticipated necessity to wear contact lens in the duration of the study.

6. Living in the same household as another participant of the study.

7. Any other specified reason as determined by clinical investigator, for example, the need to use any treatment or eyedrops not permitted by the study.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction (MGD)

Intervention

Procedure:
• Thermal Pulsation therapy

Locations

Country	Name	City	State
Singapore	Singapore National Eye Centre	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore National Eye Centre	National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ocular discomfort		3 months	No
Secondary	Tear Break Up Time (TBUT)		3 months	No
Secondary	Number of blocked meibomian glands		3 months	No
Secondary	Corneal fluorescein staining score		3 months	No
Secondary	To measure the production of tears	Schirmer's test uses paper strips inserted into the lower eyelid (conjunctival sac)for 5 minutes to measure the production of tears. Both eyes are tested at the same time. The paper is then removed and the amount of moisture is measured.	3 months	No
Secondary	Tear evaporimetry		3 months	No
Secondary	Lipid layer thickness		3 months	No